HYCEM APLICAP

Cement, Dental

ESPE GMBH & CO. KG.

The following data is part of a premarket notification filed by Espe Gmbh & Co. Kg. with the FDA for Hycem Aplicap.

Pre-market Notification Details

Device IDK963737
510k NumberK963737
Device Name:HYCEM APLICAP
ClassificationCement, Dental
Applicant ESPE GMBH & CO. KG. AM GRIESBERG 2 Seefeld,  DE D-82229
ContactBarbara Wagner
CorrespondentBarbara Wagner
ESPE GMBH & CO. KG. AM GRIESBERG 2 Seefeld,  DE D-82229
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-17
Decision Date1996-11-15
Summary:summary

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